Data Integrity & Pharma
Knowledge is of vital importance in the pharmaceutical sector. Ranging from raw data from experiments, to complex chemical formulas; from carefully performed research into medicines, to intellectual property rights, without this information the sector would be unable to function. In the event of the damage or loss of this confidential information, the organization itself and its customers could be irrevocably endangered. Awareness and responsible management of information risks are vitally important to the healthy functioning of the pharmaceutical sector. The pharmaceutical industry is thus one of the most regulated sectors. The legislation and regulations of the FDA/EU 21 CFR Part 11 set clear requirements in terms of the reliability and authenticity of data created and stored electronically.
Ordina’s Quality and Validation consultants work for leading pharmaceutical companies and their suppliers. They have a thorough knowledge of the regulations and legislation (cGxP, CFR21 Part 11, ISO 9001 of ISO 13485) and completed the Ordina Secure-by-Design program (CISSP(ISC)2, CISA, CISM). Our validation experts correctly assess your data integrity risk when using systems that store, process or retrieve data (mobile applications, cloud solutions or web applications) during each validation task